NIMAR vs Specials

NIMAR vs Specials Following on from my other blogs on NIMAR (Northern Ireland MHRA Authorised Route) I have been asked about Specials. What is the difference between NIMAR medicines and Specials? We need to be careful to distinguish between supply under the NIMAR route and Regulation 167, which is the Specials Route: Specials are unlicenced […]

NIMAR – A Closer Look

NIMAR – A Closer Look Following on from my original blog titled ‘An Introduction to NIMAR‘, today we shall have a look in more detail, particularly focussing on Distribution of NIMAR medicines to Northern Ireland Advertising and promotion of medicines on the NIMAR list How are these products supplied to Northern Ireland via NIMAR? GB-based […]

An Introduction to the Northern Ireland MHRA Authorised Route (NIMAR)

An introduction to the Northern Ireland MHRA Authorised Route (NIMAR)   What is the background to NIMAR? Following Brexit the UK Government brought in a new supply route, NIMAR, to ensure that prescription only medicines (POMs) are available to Northern Ireland (NI). What are the criteria for going down the NIMAR route? There must be […]

MHRA Active Substance Registrations

Today’s blog will help you navigate registrations for Active Pharmaceutical Ingredients (API), sometimes referred to as the ‘Drug Substance’. If you manufacture, import or distribute API(s) and you are based in the UK you must register with the Medicines and Healthcare Products Regulatory Agency (MHRA). A flow chart is available to help you decide which […]

MHRA Wholesaler Dealer’s Licence (WDA(H))

Do you need a Wholesale Dealer’s Licence (WDA(H)) to conduct your business in the UK?  If so, our blog below provides an outline of where to start and how to apply to the Medicines and Healthcare Products Regulatory Agency (MHRA). Persons operating from the UK require a Wholesale Dealer’s Licence (WDA(H)) if, in the course […]

MHRA Manufacturer’s Licence (MIA)

To manufacture, assemble or import medicinal products for human use, you need a Manufacturer’s Licence (MIA) issued by the Medicines and Healthcare Products Regulatory Agency (MHRA).  There are different manufacturer licences available depending on whether you are manufacturing licensed, unlicensed or investigational medicinal products:   Manufacturer/importer licence (MIA): Manufacture and/or assemble licensed medicinal products Import […]

Paediatric Investigation Plans (PIPs) in the UK

Today we visit the topic of Paediatric Investigation Plans (PIPs) and all related submissions to the Medicines and Healthcare products Regulatory Agency (MHRA) – the UK Health Authority. The background to Paediatric Investigation Plans has been covered in our blog on PIPs in the EU and is also applicable to the UK. Similarly to the […]

Paediatric Investigation Plans (PIPs) in the EU

Today I’m writing a short blog to introduce Paediatric Investigation Plan (PIP) submissions to the European Medicines Agency (EMA). What is a Paediatric Investigation Plan (PIP)? • A PIP is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. […]

PRIME: PRIority MEdicines

In today’s blog I will be taking a look at PRIME (priority medicines), a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. PRIME in a snapshot 1) PRIME focuses on medicines that address an unmet medical need; medicines that may offer […]

SME status in the UK

Are you a small or medium-sized enterprise (SME)? If so the Medicines and Healthcare Products Regulatory Agency (MHRA) fees legislation currently has provision for some payment waivers for SMEs. What is the criteria for a small or medium company? The criteria that needs to be met in the UK in order to be defined as […]